Household material hardship and distress among parents of children with advanced cancer: A report from the PediQUEST Response trial.

BACKGROUND: The prevalence and characteristics of household material hardship (HMH) in families of children with advanced cancer and its association with parent distress are unknown and herein described. METHODS: Parents of children aged ≥2 years with advanced cancer at five cancer centers completed baseline surveys as part of the PediQUEST Response trial. HMH (housing, energy, and food) was operationalized as binary (≥1 HMH domains), ordinal (zero, one, or two or more HMH domains), and housing based (none, nonhousing [food and/or energy], only housing, or housing + other). Associations between HMH and parent distress measured by the State-Trait Anxiety Inventory-State and the 10-item Center for Epidemiologic Studies Depression Scale were estimated via linear models adjusting for confounders. RESULTS: Among 150 parents, 41% reported ≥1 HMH (housing, 28% [only housing, 8%; housing + other, 20%]; energy, 19%; food, 27%). HMH was more prevalent among Hispanic, other non-White race, Spanish-speaking, and single parents and those with lower education (associate degree or less) or who were uninsured/Medicaid-only insured. Parents endorsing HMH reported higher anxiety (mean difference [MD], 9.2 [95% CI, 3.7-14.7]) and depression (MD, 4.1 [95% CI, 1.7-6.5]) scores compared to those without HMH. Distress increased with the number of hardships, particularly housing insecurity. Specifically, parents experiencing housing hardship, alone or combined, reported higher distress (housing only: anxiety: MD, 10.2 [95% CI, 1.8-18.5]; depression: MD, 4.9 [95% CI, 1.3-8.6]; housing + other HMH: anxiety: MD, 12.0 [95% CI, 5.2-18.9]; depression: MD, 4.8 [95% CI, 1.8-7.8]). CONCLUSIONS: HMH is highly prevalent in pediatric advanced cancer, especially among historically marginalized families. Future research should investigate whether interventions targeting HMH, particularly housing stabilization efforts, can mitigate parent distress. PLAIN LANGUAGE SUMMARY: In our cohort of parents of children with advanced cancer, household material hardship (HMH) was highly prevalent and significantly associated with higher parent distress. Housing hardship was the primary driver of this association. Families of children with advanced cancer may benefit from systematic HMH screening as well as targeted HMH interventions, especially stabilizing housing.

What is the economic and social return on investment for telephone cancer information and support services in Australia? An evaluative social return on investment study protocol.

INTRODUCTION: Over 50% of people affected by cancer report unmet support needs. To address unmet information and psychological needs, non-government organisations such as Cancer Councils (Australia) have developed state-based telephone cancer information and support services. Due to competing demands, evidence of the value of these services is needed to ensure that future investment makes the best use of scarce resources. This research aims to determine the costs and broader economic and social value of a telephone support service, to inform future funding and service provision. METHODS AND ANALYSIS: A codesigned, evaluative social return on investment analysis (SROI) will be conducted to estimate and compare the costs and monetised benefits of Cancer Council Victoria's (CCV) telephone support line, 13 11 20, over 1-year and 3-year benefit periods. Nine studies will empirically estimate the parameters to inform the SROI and calculate the ratio (economic and social value to value invested): step 1 mapping outcomes (in-depth analysis of CCV's 13 11 20 recorded call data; focus groups and interviews); step 2 providing evidence of outcomes (comparative survey of people affected by cancer who do and do not call CCV's 13 11 20; general public survey); step 3 valuing the outcomes (financial proxies, value games); step 4 establishing the impact (Delphi); step 5 calculating the net benefit and step 6 service improvement (discrete choice experiment (DCE), 'what if' analysis). Qualitative (focus groups, interviews) and quantitative studies (natural language processing, cross-sectional studies, Delphi) and economic techniques (willingness-to-pay, financial proxies, value games, DCE) will be applied. ETHICS AND DISSEMINATION: Ethics approval for each of the studies will be sought independently as the project progresses. So far, ethics approval has been granted for the first two studies. As each study analysis is completed, results will be disseminated through presentation, conferences, publications and reports to the partner organisations.

Blood gas sampling in the intensive care unit: A prospective before-and-after interventional study on the effect of an educational program on blood gas testing frequency.

BACKGROUND: Blood gas analysis is the most commonly ordered test in the intensive care unit. Each investigation, however, comes with risks and costs to the patient and healthcare system. Evidence suggests that many tests are performed with no appropriate clinical indication. OBJECTIVES: The primary aim of our prospective interventional study was to investigate the proportion of blood gases undertaken with a valid clinical indication before and after an educational intervention. A secondary aim was to examine sleep interruption secondary to blood gas sampling. METHODS: A prospective, before-and-after interventional study was conducted across two metropolitan intensive care units in Melbourne, Australia. Adults aged ≥18 years who were admitted to intensive care were eligible for inclusion. Two observation periods were conducted across a 2-week period in May and September 2022 (Periods 1 and 2), where clinicians were encouraged to record the purpose of blood gas sampling and other relevant data via an electronic questionnaire. These data were reviewed with corresponding electronic medical records. In between these periods, an interventional educational program to inform the clinical rationale for blood gas testing was delivered during July and August 2022, including introduction of a clinical guideline. RESULTS: There were 68 patients with 688 tests included in Period 1 compared to 69 patients with 756 tests in Period 2. There was no significant difference between the median number of blood gas analyses performed per patient before and after the educational intervention (6.0 tests per patient vs 5.0 tests per patient, p = 0.609). However, there was a significant increase in the percentage of tests with a valid clinical indication (49.0% vs 59.7%, p = 0.0025). The most common indications selected were routine measurement, monitoring a clinical value, change in ventilator settings/oxygen therapy, and clinical deterioration. In addition, there were a large number of patients who were awakened upon drawing of a blood sample for analysis (26.1% for Period 1 and 37.6% for Period 2, p = 0.06). CONCLUSION: The implementation of an educational program resulted in a significant increase in the proportion of blood gases performed with an appropriate clinical indication. There was, however, no reduction in the overall number of blood gases performed.

Healthy together Victoria and childhood obesity study: effects of a large scale, community-based cluster randomised trial of a systems thinking approach for the prevention of childhood obesity among secondary school students 2014-2016.

BACKGROUND: Healthy Together Victoria (HTV) was a Victorian Government initiative that sought to reduce the prevalence of overweight and obesity through targeting chronic disease risk factors including physical activity, poor diet quality, smoking, and harmful alcohol use. The intervention involved a boosted workforce of > 170 local-level staff in 12 communities; employed to deliver system activation around health and wellbeing for individuals, families and communities. A cluster randomised trial (CRT) of a systems thinking approach to obesity prevention was embedded within HTV. We present the two-year changes in overweight and obesity and associated behaviours among secondary school students across Victoria, Australia. METHODS: Twenty-three geographically bounded areas were randomised to intervention (12 communities) or comparison (11 communities). Randomly selected secondary schools within each community were invited to participate in the trial in 2014 and 2016. Students in Grade 8 (aged approximately 13-15 years) and Grade 10 (aged approximately 15-16 years) at participating schools were recruited using an opt-out approach across July-September 2014 and 2016. Primary outcomes were body mass index (BMI) and waist circumference. Secondary outcomes were physical activity, sedentary behaviour, diet quality, health-related quality of life, and depressive symptoms. Linear mixed models were fit to estimate the intervention effect adjusting for child/school characteristics. RESULTS: There were 4242 intervention children and 2999 control children in the final analysis. For boys, the two-year change showed improvement in intervention versus control for waist circumference (difference in change: - 2.5 cm; 95% confidence interval [CI]: - 4.6, - 0.5) and consumption of sugar-sweetened beverages per day (< 1 serve: 8.5 percentage points; 95% CI: 0.6, 16.5). For girls, there were no statistically significant differences between conditions. CONCLUSIONS: HTV seemed to produce favourable changes in waist circumference and sugar-sweetened beverage consumption for boys, however, no effect on BMI was observed. Although the HTV intervention was cut short, and the period between data collection points was relatively short, the changes observed in HTV contribute to the growing evidence of whole-of-community interventions targeting childhood obesity. TRIAL REGISTRATION: This trial is unregistered. The intervention itself was a policy setting delivered by government and our role was the collection of data to evaluate the effect of this natural experiment. That is, this study was not a trial from the classical point of view and we were not responsible for the intervention.

iCare - a self-directed, interactive online program to improve health and wellbeing for people living with upper gastrointestinal or hepato-pancreato-biliary cancers, and their informal carers: the study protocol for a Phase II randomised controlled trial.

BACKGROUND: Up to 70% of people diagnosed with upper gastrointestinal (GI) tract or hepato-pancreato-biliary (HPB) cancers experience substantial reductions in quality of life (QoL), including high distress levels, pain, fatigue, sleep disturbances, weight loss and difficulty swallowing. With few advocacy groups and support systems for adults with upper GI or HPB cancers (i.e. pancreas, liver, stomach, bile duct and oesophageal) and their carers, online supportive care programs may represent an alternate cost-effective mechanism to support this patient group and carers. iCare is a self-directed, interactive, online program that provides information, resources, and psychological packages to patients and their carers from the treatment phase of their condition. The inception and development of iCare has been driven by consumers, advocacy groups, government and health professionals. The aims of this study are to determine the feasibility and acceptability of iCare, examine preliminary efficacy on health-related QoL and carer burden at 3- and 6-months post enrolment, and the potential cost-effectiveness of iCare, from health and societal perspectives, for both patients and carers. METHODS AND ANALYSIS: A Phase II randomised controlled trial. Overall, 162 people with newly diagnosed upper GI or HPB cancers and 162 carers will be recruited via the Upper GI Cancer Registry, online advertisements, or hospital clinics. Patients and carers will be randomly allocated (1:1) to the iCare program or usual care. Participant assessments will be at enrolment, 3- and 6-months later. The primary outcomes are i) feasibility, measured by eligibility, recruitment, response and attrition rates, and ii) acceptability, measured by engagement with iCare (frequency of logins, time spent using iCare, and use of features over the intervention period). Secondary outcomes are patient changes in QoL and unmet needs, and carer burden, unmet needs and QoL. Linear mixed models will be fitted to obtain preliminary estimates of efficacy and variability for secondary outcomes. The economic analysis will include a cost-consequences analysis where all outcomes will be compared with costs. DISCUSSION: iCare provides a potential model of supportive care to improve QoL, unmet needs and burden of disease among people living with upper GI or HPB cancers and their carers. AUSTRALIAN AND NEW ZEALAND CLINICAL TRIALS REGISTRY: ACTRN12623001185651. This protocol reflects Version #1 26 April 2023.

Use of General Practitioner Telehealth Services During the COVID-19 Pandemic in Regional Victoria, Australia: Retrospective Analysis.

BACKGROUND: In March 2020, the Australian Government expanded general practitioner (GP) telehealth services in response to the COVID-19 pandemic. OBJECTIVE: This study sought to assess use patterns of GP telehealth services in response to changing circumstances (before and during the COVID-19 pandemic and with or without a lockdown) in regional Victoria, Australia. METHODS: We conducted a secondary analysis of monthly Medicare claims data from July 2019 to June 2021 from 140 regional GP practices in Western Victoria. The longitudinal patterns of proportion of GP telehealth consultations stratified by type of consultation (ie, videoconference vs telephone) and by geographical, consumer, and consultation characteristics were analyzed. RESULTS: Telehealth comprised 25.8% (522,932/2,025,615) of GP consultations over the 2-year period. After the introduction of the Australian telehealth expansion policy in March 2020, there was a rapid uptake in GP telehealth services (including telephone and video services), from 0% before COVID-19 to 15% (11,854/80,922) of all consultations in March 2020, peaking at 55% (50,828/92,139) in August 2020. Thereafter, the use of telehealth declined steadily to 31% (23,941/77,344) in January 2021 and tapered off to 28% (29,263/103,798) in June 2021. Telephone services and shorter consultations were the most dominant form, and those aged 15-64 years had higher telehealth use rates than younger or older age groups. The proportion of video consultations was higher during periods with government-imposed lockdowns and higher in the most socioeconomically advantaged areas compared to less socioeconomically advantaged areas. CONCLUSIONS: Our findings support the continuation of telehealth use in rural and regional Australia post pandemic. Future policy must identify mechanisms to reduce existing equity gaps in video consultations and consider patient- and system-level implications of the dominant use of short telephone consultations.

A multisite randomized controlled trial of an early palliative care intervention in children with advanced cancer: The PediQUEST Response Study Protocol.

BACKGROUND: The Pediatric Quality of Life and Evaluation of Symptoms Technology Response to Pediatric Oncology Symptom Experience (PQ-Response) intervention aims to integrate specialized pediatric palliative care into the routine care of children, adolescents, and young adults (AYAs) with advanced cancer. AIMS: To evaluate whether PQ-Response, compared to usual care, improves patient's health related quality of life (HRQoL) and symptom burden (aim 1), parent psychological distress and symptom-related stress (aim 2), and family and symptom treatment activation (aim 3). DESIGN: Multisite, randomized (1:1), controlled, un-blinded, effectiveness trial comparing PediQUEST Response (intervention) vs usual cancer care (control). SETTING: Five US large, tertiary level pediatric cancer centers. PARTICIPANTS: Children (≥2 years old)/AYAs who receive care at any of the participating sites because of advanced cancer or any progressive/recurrent solid or brain tumor and are palliative care "naïve." Target: 200 enrolled patient-parent dyads (minimum goal: 136 dyads randomized, N = 68/arm). INTERVENTIONS: PediQUEST Response: combines patient-mediated activation (weekly feedback of patient- and parent-reported symptoms and HRQoL to families and providers using the PediQUEST web system) with integration of the palliative care team. Usual Cancer Care: participants receive usual care, which can include palliative care consultation, and use PediQUEST web to answer surveys, with no feedback. METHODS: Following enrollment, patients (if ≥5 years) and one parent receive weekly PediQUEST-Surveys assessing HRQoL (Pediatric Quality of Life Inventory 4.0) and symptom burden (PediQUEST-Memorial Symptom Assessment Scale). After a 2-week run-in period, dyads who answer ≥2 PediQUEST surveys per participant (responders), are randomized (concealed allocation) and followed up for 16-weeks. Parents answer six additional surveys (parent outcomes). OUTCOMES: Primary: mean patient HRQoL score over 16-weeks as reported by a) the parent; and b) the patient if ≥5 years-old. Secondary: patient's symptom burden; parent's anxiety, depressive symptoms, symptom-related stress; family activation; and symptom treatment activation. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03408314) 1/24/18. https://clinicaltrials.gov/ct2/show/NCT03408314.

Effectiveness of an mHealth intervention to increase adherence to triage of HPV DNA positive women who have performed self-collection (the ATICA study): A hybrid type I cluster randomised effectiveness-implementation trial.

Background: Human Papillomavirus (HPV) self-collection offered by community health workers (CHWs) during home visits has been hampered by low levels of triage Pap among HPV-positive women. We investigated effectiveness of a mHealth intervention to increase adherence to triage Pap. Methods: We conducted a hybrid type I cluster randomised effectiveness-implementation trial in Jujuy, Argentina. CHWs (clusters) were eligible if actively offering HPV self-collection and served at least 26 women aged 30 years and over. Women were eligible if they conducted self-collection and provided a mobile phone number. 260 CHWs were randomly allocated (3:2 ratio) to a multi-component intervention (Up to four SMS messages sent to HPV-positive women, and one SMS message to CHWs to prompt a visit of women with no triage Pap 60 days after a positive-test), or control group (Usual care: Women instructed to attend their health centre 30 days after HPV self-collection to pick-up results). The primary effectiveness outcome was percentage of HPV-positive women with triage 120 days after the HPV-test result. We evaluated implementation of the intervention using the RE-AIM framework. Findings: 221 CHWs (132 intervention, 89 control group) contacted 5389 women; and 5351 agreed to participate (3241 intervention, 2110 control group). In total 314/445 (70·5%) HPV-positive women of the intervention group had triage at 120 days after the HPV result, compared to 163/292 (55·1%) in the control group: 15·5% point improvement; 95%CI: 6·8-24·1; relative risk: 1·28; 95%CI: 1·11-1·48. 97·2% of women accepted the intervention and 86·9% of CHWs agreed to its adoption. Interpretation: The multicomponent mHealth intervention was effective in increasing the percentage of HPV-positive women who had triage Pap, allowing for many more women at risk of cervical cancer to receive timely follow-up. Funding: National Cancer Institute of the National Institutes of Health (USA) under Award Number R01CA218306.

Testing the Accuracy of a Bedside Screening Tool Framework to Clinical Records for Identification of Patients at Risk of Malnutrition in a Rural Setting: An Exploratory Study.

This study aimed to explore the diagnostic accuracy of the Patient-Generated Subjective Global Assessment (PG-SGA) malnutrition risk screening tool when used to score patients based on their electronic medical records (EMR), compared to bedside screening interviews. In-patients at a rural health service were screened at the bedside (n = 50) using the PG-SGA, generating a bedside score. Clinical notes within EMRs were then independently screened by blinded researchers. The accuracy of the EMR score was assessed against the bedside score using area under the receiver operating curve (AUC), sensitivity, and specificity. Participants were 62% female and 32% had conditions associated with malnutrition, with a mean age of 70.6 years (SD 14.9). The EMR score had moderate diagnostic accuracy relative to PG-SGA bedside screen, AUC 0.74 (95% CI: 0.59-0.89). The accuracy, specificity and sensitivity of the EMR score was highest for patients with a score of 7, indicating EMR screen is more likely to detect patients at risk of malnutrition. This exploratory study showed that applying the PG-SGA screening tool to EMRs had enough sensitivity and specificity for identifying patients at risk of malnutrition to warrant further exploration in low-resource settings.

Efficacy and cost-effectiveness of an online mindfulness program (MindOnLine) to reduce fear of recurrence among people with cancer: study protocol for a randomised controlled trial.

INTRODUCTION: Fear of cancer recurrence (FCR) is a common condition among cancer survivors that can lead to significant levels of distress, anxiety and depression. Online mindfulness programmes may provide the mechanism to support cancer survivors manage FCR and distress, and improve people's well-being over the short, medium and long term. The primary aim of this study is to determine the potential efficacy of MindOnLine, a 9 session mindfulness-based programme for survivors of breast, prostate and colorectal cancer. A formal economic programme will also be conducted. METHODS AND ANALYSIS: A single-blind randomised controlled trial to determine the efficacy and cost-efficacy of a MindOnLine programme for cancer survivors. A total of 400 people living with cancer will be recruited via online advertisements on social media platforms, peak consumer advocacy groups or through outpatient services at healthcare providers across Victoria, Australia. People will be randomly allocated to either the MindOnLine programme (n=200) or waitlist control (n=200). Participant assessments will occur at baseline, at 9 weeks and 9-month follow-up. The primary outcome is change in Fear of Recurrence Index Score total score between baseline and 9 weeks; secondary outcomes are changes in depression and anxiety, quality of life and mindfulness. The economic analysis comprises a cost-consequences analysis where all outcomes will be compared with costs. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Peter MacCallum Cancer Centre (20-53) and Deakin University (2020-284). All participants will be required to provide written informed consent. Findings will be disseminated in peer reviewed journals and among key stakeholder organisations including hospitals, cancer and community organisations and Government. If successful the project will be rolled out nationally with a formal implementation plan. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (12620000645954); Pre-results. Registered 6 June 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379520&isReview=true.

Association between the school physical activity environment, measured and self-reported student physical activity and active transport behaviours in Victoria, Australia.

BACKGROUND: Environments within schools including the physical, social-cultural and policy/practice environments have the potential to influence children's physical activity (PA) behaviours and weight status. This Australian first study comprehensively examined the association(s) of physical, social-cultural and policy/practice environments with PA, active transport (AT) and weight status among regional primary school children. METHODS: Data were from two childhood obesity monitoring systems in regional Victoria, Australia. Measured height and weight were collected from students in Year 2 (aged approx. 7-8 years), Year 4 (9-10 years), and Year 6 (11-12 years). Self-reported PA behaviour, including AT were collected from students in Year 4 and 6 and a sub-sample wore an ActiGraph (wGT3X-BT) accelerometer for 7-days. A school physical activity environment audit was completed by the school principal and responses were used to calculate school physical activity environment scores (PAES) and active transport environment scores (ATES). Mixed effects logistic regression was used to assess the relationship between the proportion of students meeting the PA guidelines (≥60mins/day of moderate-to-vigorous PA) and PAES tertiles (low, medium, high) and those using AT and school ATES tertiles, controlling for gender, school size/type and socioeconomic composition. RESULTS: The analysed sample included 54/146 (37%) schools and 3360/5376 (64%) students. In stratified analysis, girls in schools with a medium PAES score were more likely to meet the objectively measured PA guideline compared to low PAES score (OR 2.3, 95%CI 1.27, 4.16). Similarly, students in schools with a medium or high ATES score had higher odds of self-reported AT (medium OR 3.15, 95%CI 1.67, 5.94; high OR 3.71, 95%CI: 1.80, 7.64). No association between PAES or ATES and weight status were observed. Self-reported AT among boys (OR 1.59, 95%CI 1.19, 2.13) and girls (OR 1.56, 95%CI 1.08, 2.27) was associated with higher odds of meeting self-reported PA guidelines on all 7-days than those who did not report using AT. CONCLUSIONS: In this study of regional Victorian primary schools, PA environments were only associated with girls' adherence to PA guidelines. School AT environments were strongly associated with students' AT behaviours and with increased likelihood of students being physically active.

Spanish Adaptation of the Pediatric Memorial Symptom Assessment Scale for Children, Teens, and Caregivers.

CONTEXT: There are no validated Spanish tools to assess symptom burden in pediatric cancer. The Pediatric Memorial Symptom Assessment Scale (Pediatric-MSAS) is an English valid multidimensional and comprehensive instrument. OBJECTIVES: To validate Pediatric-MSAS-Spanish (MSAS-Child, MSAS-Teen, and MSAS-Caregiver versions) in patients with cancer treated in two public hospitals in Buenos Aires, Argentina. METHODS: Cross-sectional study, classical psychometric theory. We recruited a convenience sample of 148 caregivers of children ≥ two years, 51 young children (seven to 12 years), and 48 adolescents (≥13 years). We assessed feasibility, comprehensibility, internal consistency, and convergent and known-groups validity. RESULTS: Pediatric-MSAS-Spanish was feasible, acceptable, and comprehensible. Reliability of MSAS-total and subscale scores was satisfactory (Cronbach alpha: 0.90, 0.89, 0.71, respectively, for caregiver, teen, and child MSAS-total score). MSAS-total caregiver, teen, and child scores met a priori criteria for convergent validity correlating with Pediatric Quality of Life Inventory total scores (Spearman correlation (rs) = -0.59, -0.66, and -0.32, respectively) and visual -analogue well-being scores (rs = -0.63, -0.46, and -0.4, respectively). Caregiver-teen correlation was strong for total (rs = 0.78) and physical (rs = 0.85) scores, and moderate for global distress index (rs = 0.64) and psychological (rs = 0.45) scores. MSAS-total caregiver-child correlation was moderate (rs = 0.30) and Kappa analysis showed poor agreement. All MSAS-Caregiver scores and MSAS-Teen total and physical scores differentiated inpatients/outpatients and patients on/off-treatment, while MSAS-Teen psychological and global distress index subscales or MSAS-Child scores did not. CONCLUSION: Pediatric-MSAS-Spanish is feasible and reliable for assessing symptom burden in children with cancer. Validity of MSAS-Caregiver and MSAS-Teen was largely supported. Further work on MSAS-Child is warranted.

Combined Influence of Waist and Hip Circumference on Risk of Death in a Large Cohort of European and Australian Adults.

Background Waist circumference and hip circumference are both strongly associated with risk of death; however, their joint association has rarely been investigated. Methods and Results The MONICA Risk, Genetics, Archiving, and Monograph (MORGAM) Project was conducted in 30 cohorts from 11 countries; 90 487 men and women, aged 30 to 74 years, predominantly white, with no history of cardiovascular disease, were recruited in 1986 to 2010 and followed up for up to 24 years. Hazard ratios were estimated using sex-specific Cox models, stratified by cohort, with age as the time scale. Models included baseline categorical obesity measures, age, total and high-density lipoprotein cholesterol, systolic blood pressure, antihypertensive drugs, smoking, and diabetes mellitus. A total of 9105 all-cause deaths were recorded during a median follow-up of 10 years. Hazard ratios for all-cause death presented J- or U-shaped associations with most obesity measures. With waist and hip circumference included in the same model, for all hip sizes, having a smaller waist was strongly associated with lower risk of death, except for men with the smallest hips. In addition, among those with smaller waists, hip size was strongly negatively associated with risk of death, with ≈20% more people identified as being at increased risk compared with waist circumference alone. Conclusions A more complex relationship between hip circumference, waist circumference, and risk of death is revealed when both measures are considered simultaneously. This is particularly true for individuals with smaller waists, where having larger hips was protective. Considering both waist and hip circumference in the clinical setting could help to best identify those at increased risk of death.

Outcomes of a randomized controlled trial assessing a smartphone Application to reduce unmet needs among people diagnosed with CancEr (ACE).

BACKGROUND: Smartphone technology represents an opportunity to deliver practical solutions for people affected by cancer at a scale that was previously unimaginable, such as information, appointment monitoring, and improved access to cancer support services. This study aimed to determine whether a smartphone application (app) reduced the unmet needs among people newly diagnosed with cancer. METHODS: A single blind, multisite randomized controlled trial to determine the impact of an app-based, 4-month intervention. Newly diagnosed cancer patients were approached at three health service treatment clinics. RESULTS: Eighty-two people were randomized (intervention; n = 43 and control; n = 39), average age was 59.5 years (SD: 12.9); 71% female; 67% married or in a de facto relationship. At baseline, there were no differences in participants' characteristics between the groups. No significant effects, in reducing unmet needs, were demonstrated at the end of intervention (4-month) or 12-month follow-up. Overall, 94% used the app in weeks 1-4, which decreased to 41% in weeks 13-16. Mean app use time per participant: Cancer Information, 6.9 (SD: 18.9) minutes; Appointment Schedule, 5.1 (SD: 9.6) minutes; Cancer Services 1.5 minutes (SD: 6.8); Hospital Navigation, 1.4 (SD: 2.8) minutes. CONCLUSIONS: Despite consumer involvement in the design of this smartphone technology, the app did not reduce unmet needs. This may have been due to the study being underpowered. To contribute to a meaningful understanding and improved implementation of smartphone technology to support people affected by cancer, practical considerations, such as recruitment issues and access to, and confidence with, apps, need to be considered. Australian New Zealand Clinical Trials Registration (ACTRN) Trial Registration: 12616001251415; WEF 7/9/2016.

Associations between patient and system characteristics and MET review within 48 h of admission to a teaching hospital: A retrospective cohort study.

The Medical Emergency Team (MET) has enhanced the recognition and response to clinical deterioration in acute healthcare. However, patients reviewed by the MET are at increased risk of in-hospital death. Identifying patients at risk of deterioration may improve patient outcomes. AIM: To identify patient demographic, medical characteristics and healthcare systems and processes at the time of admission (baseline), associated with Medical Emergency Team (MET) review within 48 h (MET-48 h) of admission. METHODS: Single-site, year-long, retrospective cohort comprising patients admitted for at least 24 h, using routinely collected hospital data. A three-stage modelling approach was used to identify baseline factors associated with MET-48 h RESULTS: The study included 15,695 patients with mean age 62.1 years (SD 19.6), male (53.5%), born in Australia or New Zealand (60.9%) and 51.6% held a low-income concession card. A total of 4.3% of patients received a MET review within 48 h of admission. Variables independently associated with MET-48 h in a fully adjusted logistic model included age of 80 years or more (OR = 1.37); ≥3 previous emergency admissions (OR = 1.59); Charlson Comorbidity Index 1 or 2 (OR = 1.47), or ≥ 3 (OR = 1.99); history of alcohol-related behaviour concerns (OR = 2.04), chronic heart failure (OR = 1.48); chronic obstructive pulmonary disease (OR = 1.35); admission for colorectal (OR = 2.66) or upper gastro-intestinal (OR = 1.94) surgery, respiratory or tracheostomy (OR = 2.24); immunology and infections (OR = 1.90); emergency admission (OR = 1.36); admission at night (OR = 1.74), or summer (OR = 1.41) CONCLUSIONS: This is the first study to demonstrate the potential to predict clinical deterioration using data that is readily accessible at the time of admission to hospital.

Mixed-methods approach to evaluate an mHealth intervention to increase adherence to triage of human papillomavirus-positive women who have performed self-collection (the ATICA study): study protocol for a hybrid type I cluster randomized effectiveness-implementation trial.

BACKGROUND: Cervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for self-collection with the potential to increase coverage, but still requires triage to identify which HPV+ women need diagnostic and treatment procedures. However, achieving high levels of triage adherence can be challenging, especially among socially vulnerable women. This paper describes the ATICA protocol (Application of Communication and Information Technologies to Self-Collection, for its initials in Spanish), aimed at evaluating the implementation strategy and the effectiveness of a multi-component mobile health (mHealth) intervention to increase adherence to triage among women with HPV+ self-collected tests. METHODS: We will use an effectiveness-implementation hybrid type I trial with a mixed-methods evaluation approach. A cluster randomized trial design including 200 community health workers (CHWs) will evaluate whether the mHealth intervention increases adherence to triage among HPV+ women who self-collected at home during a CHW visit within 120 days after a positive result. The intervention includes an initial mobile phone text message (SMS) alert and subsequent reminders sent to HPV+ women. For those who do not adhere to triage within 60 days of a positive HPV test, an email and SMS will be sent to the CHWs to promote contact with these women during home visits. We will use the Consolidated Framework for Implementation Research (CFIR) as an organizing and analytic framework to evaluate the implementation of the intervention while also drawing on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). We will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women. Combining both qualitative and quantitative data will provide rich insights into local implementation challenges and successes. DISCUSSION: Findings from the implementation evaluation will be applicable to programs that use or are planning to incorporate HPV self-collection and/or mHealth interventions in different settings and countries. This innovative study will also serve as a model for using implementation science in the region. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03478397 . Registered on 20 March 2018.

A pilot randomised controlled trial of an online mindfulness-based program for people diagnosed with melanoma.

PURPOSE: This study assessed the feasibility and acceptability of an online mindfulness-based intervention (MBI) for people diagnosed with melanoma. The potential benefit of the MBI on fear of cancer recurrence (FCR), worry, rumination, perceived stress and trait mindfulness was also explored. METHODS: Participants who have completed treatment for stage 2c or 3 melanoma were recruited from an outpatient clinic and randomly allocated to either the online MBI (intervention) or usual care (control). The 6-week online MBI comprised short videos, daily guided meditations and automated email reminders. Participants were asked to complete questionnaires at baseline and at 6-week post-randomisation. Study feasibility and acceptability were assessed through recruitment rates, retention and participant feedback. Clinical and psychosocial outcomes were compared between groups using linear mixed models. RESULTS: Sixty-nine (58%) eligible participants were randomised (46 in the intervention; 23 in the control group); mean age was 53.4 (SD 13.1); 54% were female. Study completion rate across both arms was 80%. The intervention was found helpful by 72% of the 32 respondents. The intervention significantly reduced the severity of FCR compared to the control group (mean difference = - 2.55; 95% CI - 4.43, - 0.67; p = 0.008). There was no difference between the intervention and control groups on any of the outcome measures. CONCLUSIONS: This online MBI was feasible and acceptable by people at high risk of melanoma recurrence. It significantly reduced FCR severity in this sample. Patients valued accessing the program at their own pace and convenience. This self-guided intervention has the potential to help survivors cope with emotional difficulties. An adequately powered randomised controlled trial to test study findings is warranted.

Self-reported fatigue in children with advanced cancer: Results of the PediQUEST study.

BACKGROUND: Pediatric cancer-related fatigue is prevalent and significantly impairs health-related quality of life, yet its patterns and correlates are poorly understood. The objectives of this study were to describe fatigue as prospectively reported by children with advanced cancer and to identify the factors associated with fatigue and associated distress. METHODS: Children (age ≥2 years) with advanced cancer (N = 104) or their parents at 3 academic hospitals reported symptoms at most weekly over 9 months using the computer-based Pediatric Quality of Life Evaluation of Symptoms Technology (PediQUEST) system. PediQUEST administered a modified version of the Memorial Symptom Assessment Scale (PQ-MSAS) as part of a randomized controlled trial. Clinical information was abstracted from medical records. Primary outcomes were: 1) fatigue prevalence (yes/no response to PQ-MSAS fatigue item) and 2) fatigue distress (composite score of severity, frequency, and bother). Multivariable models were constructed to identify factors independently associated with fatigue prevalence and scores reflecting fatigue distress (ie, burden). RESULTS: Of 920 reports, 46% (n = 425) noted fatigue. When reported, fatigue was of high frequency in 41% of respondents (n = 174), severity in 25%of respondents (n = 107), and bother in 34%of respondents (n = 143). Most reports (84%; n = 358) were associated with scores indicating fatigue distress. In multivariable analyses, fatigue was associated with older age, lower hemoglobin, and distress from particular symptoms (anorexia, nausea, sleep disturbance, sadness, and irritability). In contrast, fatigue distress was associated with distress from nausea, cough, and pain. CONCLUSIONS: Fatigue is common among children with advanced cancer and is often highly distressing. Interventions focused on uncontrolled symptoms may ease fatigue distress in children with advanced cancer.

A telephone outcall program to support caregivers of people diagnosed with cancer: utility, changes in levels of distress, and unmet needs.

PURPOSE: To evaluate the utility of a telephone outcall program for cancer caregivers and to examine longitudinal changes in their distress levels and supportive care needs. METHODS: As part of the PROTECT trial, caregivers assigned to the intervention arm (N = 108) received three telephone outcalls from a Cancer Council 13 11 20 nurse at three time points (7-10 days post-randomization, 1 and 4 months later). During each call, caregivers were screened for distress using the Distress Thermometer (range: 0-10) then six supportive care issues were raised for discussion. Participants completed a utility survey 1 month post-intervention. RESULTS: The outcall program was highly acceptable and perceived as beneficial by caregivers. Overall, 95% reported it was worth their time to take part in the outcall program and 82% stated that the program was very relevant to them. Level of distress and impact of distress decreased over time (p = 0.0031, p < 0.0001, respectively). Average call duration decreased over time (p < 0.0001) and was longer for female than male caregivers (p = 0.0009). The frequency of caregivers discussing issues related to psychological distress (p = 0.0003), health literacy (p < 0.0001), financial (p = 0.0014), and practical concerns (p = 0.0121) decreased over time. Psychological distress was more often discussed by female than male caregivers (p = 0.0153), and family issues more often by younger (< 55 years) than older caregivers (p = 0.0071). CONCLUSIONS: Utility of this outcall program was high. Caregivers' level of distress and unmet needs decreased over time. Gender and age differences emerged, which warrants the need for tailored support. Further research is necessary to identify the best method of improving access to 13 11 20 services for caregivers.

Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial.

BACKGROUND: People with a melanoma diagnosis are at risk of recurrence, developing a new primary or experiencing disease progression. Previous studies have suggested that fear of a cancer recurrence is clinically relevant in this group of patients and, if not addressed, can lead to distress. Mindfulness-based interventions have been shown to alleviate symptoms of anxiety and depression among various groups of cancer patients. Online mindfulness-based interventions have the potential to reach people unable to attend face-to-face interventions due to limitations such as cancer-related illness, transportation or time constraints. This study aims to (1) examine whether individuals with a melanoma diagnosis are willing to participate and adhere to a 6-week online mindfulness-based intervention and (2) explore potential benefits of the program on fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness to inform the design of a clinical trial. METHODS/DESIGN: This is a single-site randomised controlled trial of a feasibility study. Seventy-five participants with stage 2c or 3 melanoma will be recruited from a melanoma outpatient clinic and randomised (2:1) either to an online mindfulness-based program (intervention) or to usual care (control). The intervention is a 6-week program specifically developed for this study. It consists of videos describing the concept of mindfulness, short daily guided meditation practices (5-10 min), automated meditation reminders and instructions for applying mindfulness in daily life to enhance wellbeing. All participants will complete questionnaires at baseline and at 6-week post-randomisation. Participants in the control group will be given access to the online program at the end of the study. Primary outcomes are overall recruitment; retention; extent of questionnaire completion; and usability and acceptability of, and adherence to, the program. The secondary outcomes are fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness measured using validated instruments. DISCUSSION: This feasibility study will evaluate participants' satisfaction with the program and identify barriers to recruitment and adherence. The recruitment and data collection process will highlight methodological aspects to address in the planning of a larger scale study assessing the impact of an online mindfulness-based intervention on fear of cancer recurrence and wellbeing. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617000081314 . Registered on 16 January 2017.